Status:
COMPLETED
Experience of Using Lipano in Children With Fatty Acid Oxidation Disorders
Lead Sponsor:
Dr. Schär AG / SPA
Conditions:
Fatty Acid Oxidation Disorder
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from bi...
Eligibility Criteria
Inclusion
- Diagnosis of a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
- Patients from birth to 18 months
- Written informed consent obtained from patient or parental caregiver
Exclusion
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study
- Patients over 18 months of age
Key Trial Info
Start Date :
June 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04400422
Start Date
June 20 2018
End Date
September 20 2018
Last Update
May 22 2020
Active Locations (1)
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1
Russian Children's Hospital Center for Orphan Diseases
Moscow, Russia, 117513